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To Evaluate the Performance and Safety of YVOIRE Y Solution 360 Versus Comparator for Lips and Perioral Area.

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LG Chem

Status

Terminated

Conditions

Lip Augmentation

Treatments

Device: Juvéderm VOLBELLA
Device: YVOIRE Y-Solution 360

Study type

Interventional

Funder types

Industry

Identifiers

NCT04299295
LG-HACL023

Details and patient eligibility

About

A Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 on Lips and Perioral Area.

Full description

This is a Randomized, Multicenter, Evaluator-Blinded, Active-Controlled, Parallel-Group Study to Evaluate the Performance and Safety of YVOIRE Y-Solution 360 Versus Comparator for Temporary Enhancement and Pouting of the Lips for Lip Augmentation and Correction of Perioral Area

Enrollment

118 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Male or female 18 years or above age.
  • 1 or 2 of the 5-point (0-4) LFRS (Lip Fullness Rating Scale).
  • Agree to use proper contraception as guided in the protocol.
  • Signed for Informed Consent.

Exclusion criteria

  • have lip tattoos, piercings, facial hair, or scars that would interfere with visualization of the lips and perioral area
  • who have dentures or any device covering all or part of the upper palate, and/or severe malocclusion or dentofacial or maxillofacial deformities
  • have undergone oral surgery within 6 weeks
  • have received permanent facial implants in the face or neck, or are planning to be implanted with any of these products
  • have undergone semi-permanent filler in lower face within 24 months
  • have undergone temporary dermal filler treatment in the lower face within 12 months
  • Have undergone facial tissue augmentation or facial treatment with fat or botulinum injections in the lower face within 6 months
  • Have undergone mesotherapy, face lift, laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, moderate or greater depth chemical peel, or other ablative procedures in face or neck within 6 months
  • have used lip plumping products within 10 days

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

118 participants in 2 patient groups

YVOIRE Y-Solution 360
Experimental group
Description:
Hyaluronic acid dermal filler
Treatment:
Device: YVOIRE Y-Solution 360
Juvéderm VOLBELLA
Active Comparator group
Description:
Hyaluronic acid dermal filler
Treatment:
Device: Juvéderm VOLBELLA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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